COPDNCT05995847
Effectiveness of Harmonica Playing in Improving Lung Function Among COPD Patients
A study testing Harmonica playing program plus basic PR care with routine follow-up and Basic PR care with routine follow-up in people with COPD, run by The First Affiliated Hospital of Guangzhou Medical University at 2 sites in China.
Trial summary
Although it has been documented that harmonica playing plays a role in the pulmonary rehabilitation (PR) of patients with chronic obstructive pulmonary disease (COPD), current studies are limited by small sample sizes, uncomprehensive outcome indicators, and short intervention durations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Harmonica playing program plus basic PR care with routine follow-up and Basic PR care with routine follow-up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 2 sitesChina
- Study dates
- 5 Dec 2023to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ● Clinical diagnosis of COPD.
Who cannot join
- Individuals with a history of COPD exacerbation within the last 6 weeks. An exacerbation is defined as a deterioration in at least two respiratory symptoms that necessitate hospitalization.
- Individuals with comorbidities that affect physical activity, such as severe cardiac or neurological disorders, cancer, or musculoskeletal problems.
- Individuals with cognitive disorders.
- Individuals unable to speak or understand spoken/written Chinese.
- Individuals who have participated in pulmonary rehabilitation (or any other structured, disease-related physical training) within the previous 6 months.
- Individuals who have played the harmonica, or other similar instrument, regularly in the previous 6 months.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510006
- Recruiting
The first affiliated hospital of Guangzhou Medical Univeristy
Guangzhou
Wenli Chen, 8613560329703, 463357810@qq.com
Qiuxuan Zeng, 8613434289929, zengqiuxuan@163.com
About this study
Official title: The Effectiveness of Harmonica Playing in Improving Lung Function Among In-home Patients With Chronic Obstructive Pulmonary Disease
Although it has been documented that harmonica playing plays a role in the pulmonary rehabilitation (PR) of patients with chronic obstructive pulmonary disease (COPD), current studies are limited by small sample sizes, uncomprehensive outcome indicators, and short intervention durations. Thus, the investigators aim to compare the harmonica combination group with the basic-PR-care group in terms of improving health outcomes among COPD patients, such as lung function, self-efficacy, quality of life, compliance with training, and emotional distress.
Read the detailed description
Chronic Obstructive Pulmonary Disease (COPD) is an avoidable and treatable condition characterized by chronic respiratory symptoms and airflow obstruction, primarily due to airway and/or alveolar abnormalities from toxic elements. Because of COPD's high prevalence and mortality, its prevention and treatment pose a global public health challenge that needs addressing.
Pulmonary rehabilitation (PR) is considered a cornerstone of COPD management because it effectively improves exercise tolerance, exercise-induced dyspnea, fatigue, and health-related quality of life. Inspiratory muscle training (IMT) plays an important role in PR. Studies suggest that harmonica playing can emulate inspiratory muscle training, enhancing pulmonary function in COPD patients. Additionally, as a music therapy approach, harmonica playing may alleviate the emotional distress often seen in these individuals.
However, existing studies haven't provided robust evidence to support harmonica playing's efficacy in enhancing COPD patients' health outcomes due to limitations like small sample sizes, non-trial study designs, incomplete outcomes, and short intervention durations. It remains unclear whether harmonica playing can improve COPD patients' physiological and psychological health outcomes.
This study's primary aim is to evaluate whether harmonica playing can boost the lung function of COPD patients compared to those only receiving basic PR care in the control group. The secondary aim is to investigate if harmonica playing can enhance other outcomes related to physical and psychological aspects, such as self-efficacy, quality of life, training compliance, and emotional distress.
Methods:
This is a single-center RCT with a low-risk intervention.
Patients who meet the inclusion criteria and do not meet any exclusion criteria will be randomly assigned to either the intervention or control group. The intervention group will receive a harmonica playing program in addition to basic PR care, excluding the pursed-lip breathing exercise, along with routine follow-up. In contrast, the control group will receive basic PR care, which includes the pursed-lip breathing exercise, along with routine follow-up.
Details of the treatments in both groups are provided in the intervention section.
At baseline and six months post-intervention, the investigators will collect clinical evaluations including:
Lung function (Pulmonary function laboratory tests will be performed only at baseline and six months post-intervention) Physical activity Symptoms Quality of life Psychological well-being (focusing on depression and anxiety) Self-efficacy Fatigue Self-reported compliance and satisfaction Outcome measures will be detailed in the subsequent section.
FEV1% predicted is a commonly used outcome indicator in PR and is suitable for sample size estimation. According to results from similar studies, the minimum clinically important difference (MCID) for FEV1% predicted is 4%, with a baseline standard deviation (SD) of 10%. Given a two-tailed significance level of 0.05 and a power of 80%, each group requires a minimum of 99 participants. Accounting for a drop-out rate of 20%, an estimated 248 patients (124 per group) will be enrolled.
Statistical evaluation will be performed using the SPSS 21.0 program. The intention-to-treat (ITT) approach will be adopted for data analysis.
- Conditions
- COPD
- Being tested
- Harmonica playing program plus basic PR care with routine follow-up, Basic PR care with routine follow-up
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Harmonica playing program plus basic PR care with routine follow-upBehavioural
The intervention will last for a total of six months. During this period, patients are expected to play the harmonica daily for 30 minutes, five days a week. Additionally, patients will receive basic pulmonary rehabilitation (PR) care, which includes self-management education, exercise training, and breathing training, as well as routine follow-up. All training sessions are home-based and will take place five days per week for the duration of six months.
Basic PR care with routine follow-upBehavioural
These patients will receive basic pulmonary rehabilitation (PR) care, which includes self-management education, exercise training, and breathing training, as well as routine follow-up. All training sessions are home-based and will take place five days per week for the duration of six months
| Study group | Role | What they receive |
|---|---|---|
| harmonica combination group | Experimental | These patients will participate in a six-month harmonica playing program, in addition to receiving basic pulmonary rehabilitation (PR) care, which includes self-management education, exercise training, and breathing training, as well as routine follow-up. All training sessions are home-based and will take place five days per week for six months. Receives: Behavioral: Harmonica playing program plus basic PR care with routine follow-up |
| basic-PR-care group | Active comparator | These patients will receive basic pulmonary rehabilitation (PR) care, which includes self-management education, exercise training, and breathing training, as well as routine follow-up. All training sessions are home-based and will take place five days per week for six months. Receives: Behavioral: Basic PR care with routine follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FEV1 % predicted
The investigators will assess patients' lung function using a lung function detector to obtain the outcome of FEV1 % predicted.
Measured: At baseline, after 1 month, after 3 months, and after 6 months of intervention
Secondary outcomes (13)
Change in individual strength
The CIS-Fatigue Scale will be used to assess the level of individual fatigue. The total score for the CIS-Fatigue can range from 7 to 56. A higher score indicates a lower level of individual strength.
Measured: At baseline, after 1 month, after 3 months, and after 6 months of intervention
Change in fatigue
The FACIT-F scale will be used to assess changes in fatigue. The total score for the FACIT-F scale can range from 0 to 52. A higher score indicates a higher level of fatigue.
Measured: At baseline, after 1 month, after 3 months, and after 6 months of intervention
Compliance and satisfaction
A self-designed questionnaire will be utilized, which contains questions about participants' compliance and satisfaction.
Measured: After 6 months of intervention
Change in self-efficacy
The Chinese version of the COPD Self-Efficacy Scale for Chronic (CSES) will be employed to evaluate patients' disease self-efficacy. This is a 31-item scale, with responses ranging from 1 (not confident at all) to 5 (very confident). Responses are summed to produce a total score for each participant. Scores can range from 31 to 155, with higher scores indicating greater self-efficacy.
Measured: At baseline, after 1 month, after 3 months, and after 6 months of intervention
Change in psychological well-being
The Hospital Anxiety and Depression Scale (HADS) will be used to assess patients' anxiety and depression. Higher scores indicate increased levels of anxiety or depression. Subscale scores of ≥11 are considered indicative of a 'definite case'. Scores of 8 to 10 suggest a 'suspicious case', and scores of 0 to 7 are deemed a 'noncase' for anxiety or depression.
Measured: At baseline, after 1 month, after 3 months, and after 6 months of intervention
Change in quality of life
The St. George's Respiratory Questionnaire (SGRQ) will be used to assess patients' quality of life. The total score ranges from 0 to 100. A score of 0 indicates no impairment in quality of life, while a score of 100 denotes maximum impairment. A higher score indicates a poorer quality of life.
Measured: At baseline, after 1 month, after 3 months, and after 6 months of intervention
Change in symptoms
The COPD Assessment Test (CAT) will be employed to assess participants' symptom changes. The total score can range from 0 to 40. A higher score on the CAT indicates a more severe impact of COPD on a patient's health status and thus worse outcomes.
Measured: At baseline, after 1 month, after 3 months, and after 6 months of intervention
Change in level of physical activity
The 6-minute walk distance, which represents the level of physical activity, will be assessed using a 6-minute walk test. A shorter 6MWD typically indicates poorer exercise tolerance and correlates with more severe disease.
Measured: At baseline, after 1 month, after 3 months, and after 6 months of intervention
Changes in levels of breathlessness
The Modified Medical Research Council (mMRC) Dyspnea Scale will be used to gauge participants' level of breathlessness. Scores range from 0 to 4, with a higher score signifying more severe breathlessness.
Measured: At baseline, after 1 month, after 3 months, and after 6 months of intervention
Changes in clinical control
The Clinical COPD Questionnaire (CCQ) will be utilized to gauge clinical control in participants. Total scores range from 0 to 6, with a higher CCQ score signifying poorer clinical control and a worse health status.
Measured: At baseline, after 1 month, after 3 months, and after 6 months of intervention
Social support status
The Multidimensional Scale of Perceived Social Support (MSPSS) will be used for assess social support. The scores can range from 12 and 84. A higher score indicates greater perceived social support
Measured: At baseline, after 1 month, after 3 months, and after 6 months of intervention
Change in inspiratory muscle strength
The investigators will assess patients' inspirtaory muscle strength using a lung function detector.
Measured: At baseline, after 1 month, after 3 months, and after 6 months of intervention
Change in expiratory muscle strength
The investigators will assess patients' expiratory muscle strength using a lung function detector.
Measured: At baseline, after 1 month, after 3 months, and after 6 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start5 Dec 2023
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeng Qiuxuan, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995847
- Sponsor's protocol ID
- ZQiuxuan
- Status last verified
- Feb 2024
- First submitted
- 3 Jul 2023
- Last updated
- 23 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen W, Huang J, Zeng Q, Ye ZJ, Li J, Li J. Patient perspectives on harmonica playing as an intervention for chronic obstructive pulmonary disease: a qualitative study. BMJ Open. 2026 Feb 6;16(2):e112115. doi: 10.1136/bmjopen-2025-112115.
PubMed 41651516Zeng Q, Lin X, Chen W, Fong DYT, Li J, Li J. Effectiveness of a harmonica-integrated, tele-supervised home-based pulmonary rehabilitation program on lung function and comprehensive health outcomes in patients with chronic obstructive pulmonary disease: a randomized controlled trial protocol. Front Public Health. 2025 Jan 29;13:1541866. doi: 10.3389/fpubh.2025.1541866. eCollection 2025.
PubMed 39944075
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Harmonica Playing in Improving Lung Function Among In-home Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT05995847
- Acronym / sponsor ID
- ZQiuxuan
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 16 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although it has been documented that harmonica playing plays a role in the pulmonary rehabilitation (PR) of patients with chronic obstructive pulmonary disease (COPD), current studies are limited by small sample sizes, uncomprehensive outcome indicators, and short intervention durations. Thus, the investigators aim to compare the harmonica combination group with the basic-PR-care group in terms of improving health outcomes among COPD patients, such as lung function, self-efficacy, quality of life, compliance with training, and emotional distress.
Detailed description
Chronic Obstructive Pulmonary Disease (COPD) is an avoidable and treatable condition characterized by chronic respiratory symptoms and airflow obstruction, primarily due to airway and/or alveolar abnormalities from toxic elements. Because of COPD's high prevalence and mortality, its prevention and treatment pose a global public health challenge that needs addressing.
Pulmonary rehabilitation (PR) is considered a cornerstone of COPD management because it effectively improves exercise tolerance, exercise-induced dyspnea, fatigue, and health-related quality of life. Inspiratory muscle training (IMT) plays an important role in PR. Studies suggest that harmonica playing can emulate inspiratory muscle training, enhancing pulmonary function in COPD patients. Additionally, as a music therapy approach, harmonica playing may alleviate the emotional distress often seen in these individuals.
However, existing studies haven't provided robust evidence to support harmonica playing's efficacy in enhancing COPD patients' health outcomes due to limitations like small sample sizes, non-trial study designs, incomplete outcomes, and short intervention durations. It remains unclear whether harmonica playing can improve COPD patients' physiological and psychological health outcomes.
This study's primary aim is to evaluate whether harmonica playing can boost the lung function of COPD patients compared to those only receiving basic PR care in the control group. The secondary aim is to investigate if harmonica playing can enhance other outcomes related to physical and psychological aspects, such as self-efficacy, quality of life, training compliance, and emotional distress.
Methods:
This is a single-center RCT with a low-risk intervention.
Patients who meet the inclusion criteria and do not meet any exclusion criteria will be randomly assigned to either the intervention or control group. The intervention group will receive a harmonica playing program in addition to basic PR care, excluding the pursed-lip breathing exercise, along with routine follow-up. In contrast, the control group will receive basic PR care, which includes the pursed-lip breathing exercise, along with routine follow-up.
Details of the treatments in both groups are provided in the intervention section.
At baseline and six months post-intervention, the investigators will collect clinical evaluations including:
Lung function (Pulmonary function laboratory tests will be performed only at baseline and six months post-intervention) Physical activity Symptoms Quality of life Psychological well-being (focusing on depression and anxiety) Self-efficacy Fatigue Self-reported compliance and satisfaction Outcome measures will be detailed in the subsequent section.
FEV1% predicted is a commonly used outcome indicator in PR and is suitable for sample size estimation. According to results from similar studies, the minimum clinically important difference (MCID) for FEV1% predicted is 4%, with a baseline standard deviation (SD) of 10%. Given a two-tailed significance level of 0.05 and a power of 80%, each group requires a minimum of 99 participants. Accounting for a drop-out rate of 20%, an estimated 248 patients (124 per group) will be enrolled.
Statistical evaluation will be performed using the SPSS 21.0 program. The intention-to-treat (ITT) approach will be adopted for data analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| harmonica combination group | Experimental | Behavioral: Harmonica playing program plus basic PR care with routine follow-upThese patients will participate in a six-month harmonica playing program, in addition to receiving basic pulmonary rehabilitation (PR) care, which includes self-management education, exercise training, and breathing training, as well as routine follow-up. All training sessions are home-based and will take place five days per week for six months. |
| basic-PR-care group | Active comparator | Behavioral: Basic PR care with routine follow-upThese patients will receive basic pulmonary rehabilitation (PR) care, which includes self-management education, exercise training, and breathing training, as well as routine follow-up. All training sessions are home-based and will take place five days per week for six months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ● Clinical diagnosis of COPD.
Key exclusion criteria (6 listed)
- Individuals with a history of COPD exacerbation within the last 6 weeks. An exacerbation is defined as a deterioration in at least two respiratory symptoms that necessitate hospitalization.
- Individuals with comorbidities that affect physical activity, such as severe cardiac or neurological disorders, cancer, or musculoskeletal problems.
- Individuals with cognitive disorders.
- Individuals unable to speak or understand spoken/written Chinese.
- Individuals who have participated in pulmonary rehabilitation (or any other structured, disease-related physical training) within the previous 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Harmonica playing program plus basic PR care with routine follow-upThe intervention will last for a total of six months. During this period, patients are expected to play the harmonica daily for 30 minutes, five days a week. Additionally, patients will receive basic pulmonary rehabilitation (PR) care, which includes self-management education, exercise training, and breathing training, as well as routine follow-up. All training sessions are home-based and will take place five days per week for the duration of six months. | Behavioural | harmonica combination group |
| Basic PR care with routine follow-upThese patients will receive basic pulmonary rehabilitation (PR) care, which includes self-management education, exercise training, and breathing training, as well as routine follow-up. All training sessions are home-based and will take place five days per week for the duration of six months | Behavioural | basic-PR-care group |
Primary outcome
Change in FEV1 % predicted
Time frame: At baseline, after 1 month, after 3 months, and after 6 months of intervention
The investigators will assess patients' lung function using a lung function detector to obtain the outcome of FEV1 % predicted.
13 secondary outcomes
Change in individual strength
Time frame: At baseline, after 1 month, after 3 months, and after 6 months of intervention
Change in fatigue
Time frame: At baseline, after 1 month, after 3 months, and after 6 months of intervention
Compliance and satisfaction
Time frame: After 6 months of intervention
Change in self-efficacy
Time frame: At baseline, after 1 month, after 3 months, and after 6 months of intervention
Change in psychological well-being
Time frame: At baseline, after 1 month, after 3 months, and after 6 months of intervention
Change in quality of life
Time frame: At baseline, after 1 month, after 3 months, and after 6 months of intervention
Change in symptoms
Time frame: At baseline, after 1 month, after 3 months, and after 6 months of intervention
Change in level of physical activity
Time frame: At baseline, after 1 month, after 3 months, and after 6 months of intervention
Changes in levels of breathlessness
Time frame: At baseline, after 1 month, after 3 months, and after 6 months of intervention
Changes in clinical control
Time frame: At baseline, after 1 month, after 3 months, and after 6 months of intervention
Social support status
Time frame: At baseline, after 1 month, after 3 months, and after 6 months of intervention
Change in inspiratory muscle strength
Time frame: At baseline, after 1 month, after 3 months, and after 6 months of intervention
Change in expiratory muscle strength
Time frame: At baseline, after 1 month, after 3 months, and after 6 months of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Derived from this study: PubMed 41651516Chen W, Huang J, Zeng Q, Ye ZJ, Li J, Li J. Patient perspectives on harmonica playing as an intervention for chronic obstructive pulmonary disease: a qualitative study. BMJ Open. 2026 Feb 6;16(2):e112115. doi: 10.1136/bmjopen-2025-112115.
- Derived from this study: PubMed 39944075Zeng Q, Lin X, Chen W, Fong DYT, Li J, Li J. Effectiveness of a harmonica-integrated, tele-supervised home-based pulmonary rehabilitation program on lung function and comprehensive health outcomes in patients with chronic obstructive pulmonary disease: a randomized controlled trial protocol. Front Public Health. 2025 Jan 29;13:1541866. doi: 10.3389/fpubh.2025.1541866. eCollection 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Harmonica playing program plus basic PR care with routine follow-up and Basic PR care with routine follow-up in people with COPD, run by The First Affiliated Hospital of Guangzhou Medical University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qiuxuan Zeng, Bachelor (+86 15975789501, zengqiuxuan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in FEV1 % predicted (time frame: At baseline, after 1 month, after 3 months, and after 6 months of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05995847, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.